Study of NMS-1286937 in Adult Patients With Advanced/Metastatic Solid Tumors

NCT01014429 | Completed Phase 1

• 1 other identifier: PLKA-937-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of NMS-1286937, a polo-like-kinase 1 inhibitor, in patients with advanced metastatic solid tumor.

Conditions

Advanced or Metastatic Solid Tumors

Keywords

Phase I dose escalation study; Advanced or metastatic solid tumors; PLK 1 inhibitor; Adult patients

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) and first cycle dose limiting toxicities (DLTs)

  Cycle 1

Secondary Outcomes (2)

• Evaluation of pharmacokinetics: plasma concentration at different times after dosing, area under the curve (AUC), maximum plasma concentration (Cmax), clearance (CL), volume of distribution, half-life (t½)

  Cycles 1 and 2

• Evaluation of pharmacodynamics: biomarkers modulation in skin and/or tumor samples of consenting patients

  Cycles 1 and 2

Study Arms (1)

1

EXPERIMENTAL

Drug: NMS-1286937

Interventions

NMS-1286937 DRUG

Single Arm, dose escalation study. No. of cycles: until progression or unacceptable toxicity develops.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced/metastatic solid tumors, for which no effective standard therapy exist
• Adult patients (age \>/= 18)
• ECOG performance status (PS) 0 or 1
• Life expectancy of at least 3 months
• Adequate renal, liver function and bone marrow reserve
• Prior cancer therapy allowed, with max 4 regimens of chemotherapy. Washout: at least 4 wks (6 wks for nitrosoureas, mitomycin C and liposomal doxorubicin) and all toxicities recovered to CTC Grade \</=1
• Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
• Women and men of child producing potential should agree to use effective contraception
• Capability to swallow capsules intact

You may not qualify if:

• Known uncontrolled/symptomatic brain metastases
• Currently active second malignancy
• Major surgery in the last 4 wks
• Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
• Pregnancy or breast-feeding women
• Known active infections
• History of drug allergic reactions
• Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption.
• Documented gastrointestinal ulcer
• Other severe concurrent acute or chronic medical or psychiatric condition that could compromise protocol objectives

Sponsors & Collaborators

• Nerviano Medical Sciences: lead

Study Sites (1)

Arizona TGen Clinical Research Services at Scottsdale Heathcare

Scottsdale, Arizona, 85258, United States

Location

Study Officials

• Mariangela Mariani, Biol Sci D

  Nerviano Medical Sciences

  STUDY DIRECTOR

• Maria Adele Pacciarini, Biol Sci D

  Nerviano Medical Sciences

  STUDY DIRECTOR

• Glen J Weiss, MD

  Arizona TGen Clinical Reserch Services at Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: November 1, 2009
• Primary Completion: October 1, 2011
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

US (1)